A Long-term Safety Study of Latanoprost in Pediatric Patients With Glaucoma and Ocular Hypertension: A Prospective Cohort Study.

PURPOSE

The objective was to assess the long-term effect of treatment with latanoprost on ocular development and safety in pediatric patients with glaucoma and ocular hypertension.

DESIGN

Prospective cohort study.

METHODS

This was a prospective 3-year cohort study conducted in 14 countries in Europe and South America. Patients aged < 18 years with glaucoma or ocular hypertension were enrolled into either the latanoprost or non-prostaglandin (non-PG) group in this observational study. The primary endpoint was change in best-corrected visual acuity (BCVA) from baseline to 3 years. Several secondary endpoints were evaluated, including corneal thickness and ocular hyperpigmentation. For treatment comparison, analysis of covariance (ANCOVA) was used for continuous endpoints and Fisher exact test was applied for proportion of participants with clinically significant deterioration events.

RESULTS

A total of 175 patients were enrolled: 102 in the latanoprost group (median follow-up: 36.7 months) and 73 in the non-PG group (median follow-up: 36.1 months). There was no statistically significant difference between the latanoprost and the non-PG groups (aged 5 to <18 years) in BCVA change from baseline (least square mean logMAR difference -0.03 [95% confidence interval: -0.12, 0.06]), corneal thickness, or ocular hyperpigmentation.

CONCLUSIONS

Latanoprost had an acceptable safety profile with no evidence of inducing clinically meaningful or statistically significant changes in ocular development or ocular hyperpigmentation in pediatric patients with glaucoma and ocular hypertension.